Clinical Study Monitor (PK/PD & Biomarkers Focus)- CDI- F/M
Core
Operational oversight of PK, PD, and biomarker components in early and late phase clinical trials, ensuring sample management, data integrity, and regulatory compliance.
Role type
Clinical Study Monitor (PK/PD & Biomarkers)
Builds
Clinical trial data and regulatory documentation for pharmaceutical dermo-cosmetics R&D
Domain
Pharmaceutical R&D / Clinical Pharmacology / Biomarkers
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study conduct, GCP compliance, sample management workflows, bioanalytical processes, regulatory documentation, clinical trial governance, CRO/vendor management, PK/PD principles, biomarker assays, clinical databases (EDC/LIMS), document management systems (RIM)
Preferred skills
NCA pharmacokinetic data analysis, WNL software proficiency, regulatory documentation expertise, prior interaction with CROs and external laboratories
Technologies
WNL, EDC, LIMS, RIM
Responsibilities
Participate in study design and planning with Clinical Pharmacology and Biomarker teams; oversee CROs for end-to-end sample management (collection, handling, logistics, storage, shipment); ensure timely and compliant execution of bioanalysis activities; manage, clean, and validate PK/PD and biomarker datasets; coordinate with data management and statisticians for robust analyses; oversee outsourced analyses and reporting by CROs or external partners; track budgets and manage timelines for PK/PD and bioanalytical activities.
Seniority
Mid-level, hands-on IC
